VISIPAQUE- iodixanol injection, solution
GE Healthcare Inc.
PHARMACY BULK PACKAGE�NOT FOR DIRECT INFUSION
NOT FOR INTRATHECAL USE
DESCRIPTION
VISIPAQUE� (iodixanol) Injection, 5,5?-[(2-hydroxy-1,3-propanediyl)bis (acetylimino)]bis[N,N'-bis(2,3-dihydroxypropyl)-2,4,6- triiodo-1,3- benzenedicarboxamide], is a dimeric, isosmolar, nonionic, water-soluble, radiographic contrast medium with a molecular weight of 1550.20 (iodine content 49.1%). It is administered by intravascular injection.
VISIPAQUE (C35 H44 I6 N6 O15 )
VISIPAQUE Injection is provided as a ready-to-use sterile, pyrogen-free, colorless to pale yellow solution, in Pharmacy Bulk Package, in concentrations of 270 and 320 mg of organically bound iodine per mL (550 and 652 mg of iodixanol per mL, respectively). A Pharmacy Bulk Package is used to dispense multiple single doses, utilizing a suitable transfer device. Sodium chloride and calcium chloride have been added, resulting in an isotonic solution for injection. VISIPAQUE 270 (270 mgI/mL) contains 0.074 mg calcium chloride dihydrate per mL and 1.87 mg sodium chloride per mL, and VISIPAQUE 320 (320 mgI/mL) contains 0.044 mg calcium chloride dihydrate per mL and 1.11 mg sodium chloride per mL, providing for both concentrations a sodium/calcium ratio equivalent to blood. In addition, each milliliter contains 1.2 mg tromethamine and 0.1 mg edetate calcium disodium. The pH is adjusted to 7.4 with hydrochloric acid and/or sodium hydroxide to achieve a range between pH 6.8 and 7.7 at 22�C. All solutions are terminally sterilized by autoclaving and contain no preservatives.
CLINICAL PHARMACOLOGY
GENERAL
Iodixanol is a dimeric, isosmolar, nonionic, water soluble, iodinated x-ray contrast agent for intravascular administration.
Intravascular injection of iodixanol opacifies those vessels in the path of flow of the contrast agent, permitting radiographic visualization of the internal structures until significant dilution and elimination occurs.
INTRAVENOUS ADMINISTRATION
Excretory urography, contrast-enhanced computed tomography (CECT) of the head, CECT of the body, and peripheral venography were studied with either one or both VISIPAQUE Injection concentrations (270 mgI/mL or 320 mgI/mL). In these intravenous studies, diagnostic visualization ratings were good or excellent in 96-100% of the patients and a radiologic diagnosis was made in all (100%) of the patients given VISIPAQUE Injection. Results were compared to those of the active control. The number of patients studied in each indication is provided below.
Excretory urography was evaluated in one uncontrolled, unblinded clinical trial in 40 patients, 20 given VISIPAQUE Injection 270 mgI/mL and 20 given VISIPAQUE Injection 320 mgI/mL, and in two randomized, double-blind clinical trials in 50 adult patients given VISIPAQUE Injection 270 mgI/mL, 50 patients given VISIPAQUE Injection 320 mgI/mL, and 50 patients given iohexol 300 mgI/mL. Visualization ratings were good or excellent in 100% of the patients given VISIPAQUE; a radiologic diagnosis was made in the majority of the patients. The results were similar to those of the active control. Confirmation of the radiologic findings by other diagnostic methods was not obtained.
CECT of the head was evaluated in two randomized, double-blind clinical trials in 49 adult patients given VISIPAQUE Injection 270 mgI/mL, in 50 patients given VISIPAQUE Injection 320 mgI/mL, and in 49 patients given iohexol 300 mgI/mL. CECT of the body was evaluated in three randomized, double-blind clinical trials in 104 adult patients given VISIPAQUE Injection 270 mgI/mL, in 109 patients given VISIPAQUE Injection 320 mgI/mL, and in 101 patients given iohexol 300 mgI/mL. In both CECT of the head and body, visualization ratings were good or excellent in 100% of the patients given VISIPAQUE; a radiologic diagnosis was made in the majority of the patients. The results were similar to those of active controls. Confirmation of the radiologic findings by other diagnostic methods was not obtained.
Peripheral venography was evaluated in two randomized, double-blind clinical trials in 46 adult patients given VISIPAQUE Injection 270 mgI/mL and in 50 patients given iohexol 300 mgI/mL. Visualization ratings were good or excellent in 100% of the patients given VISIPAQUE; a radiologic diagnosis was made in the majority of the patients. The results were similar to those of the active control. Confirmation of the radiologic findings by other diagnostic methods was not obtained.
Visipaque Indications and Usage
INTRA-ARTERIAL 1
VISIPAQUE Injection (270 mgI/mL) is indicated for intra-arterial digital subtraction angiography.
VISIPAQUE Injection (320 mgI/mL) is indicated for angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography.
INTRAVENOUS 1
VISIPAQUE Injection (270 mgI/mL) is indicated for CECT imaging of the head and body, excretory urography, and peripheral venography.
VISIPAQUE Injection (320 mgI/mL) is indicated for CECT imaging of the head and body, and excretory urography.
1
For information on the concentrations and doses for the pediatric population see the Precautions�Pediatric Use, Clinical Pharmacology�Special Populations, and Dosage and Administration sections.
CONTRAINDICATIONS
VISIPAQUE Injection is not indicated for intrathecal use.
In the pediatric population prolonged fasting and the administration of a laxative before VISIPAQUE injection are contraindicated.
INFORMATION FOR PATIENTS
Patients receiving an iodinated intravascular contrast agent should be instructed to:
Inform your physician if you are pregnant (see PRECAUTIONS � Pregnancy Category B).
Inform your physician if you are diabetic or if you have multiple myeloma, pheochromocytoma, homozygous sickle cell disease, or known thyroid disorder (see WARNINGS).
Inform your physician if you are allergic to any drugs or food, or if you have immune, autoimmune or immune deficiency disorders. Also inform your physician if you had any reactions to previous injections of dyes used for x-ray procedures (see PRECAUTIONS, General).
Inform your physician about all medications you are currently taking, including nonprescription (over-the-counter) drugs, before you have this procedure.
DOSAGE AND ADMINISTRATION
For Pediatric dosing see the end of this Dosage and Administration section.
GENERAL
The combination of volume and concentration of VISIPAQUE Injection to be used should be individualized, accounting for factors such as age, body weight, size of the vessel, and rate of blood flow within the vessel. Specific dose adjustment studies for age, gender, weight and renal function have not been conducted with VISIPAQUE. As with other iodinated contrast agents, lower doses may have less risk. The efficacy of VISIPAQUE Injection below doses recommended has not been established. Other factors, such as pathology anticipated, degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed, should be considered.
The maximum recommended total dose of iodine is 80 grams.
If an adverse reaction occurs during injection, consider stopping the injection immediately if warranted by the nature and severity of the event.
